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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dressing,wound,occlusive
Regulation Description Occlusive wound dressing.
Product CodeNAD
Regulation Number 878.4020
Device Class 1


Premarket Reviews
ManufacturerDecision
BOSTON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ENZYSURGE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 72
Foreign material present in device 58
Failure to Adhere or Bond 56
Device operates differently than expected 17
Difficult to remove 12
Delivered as unsterile product 11
Unsealed device packaging 10
No Information 9
Packaging issue 8
No code available 7
Device packaging compromised 7
Unknown (for use when the device problem is not known) 7
Sticking 6
Human-Device Interface Issue 5
Defective item 4
Material integrity issue 4
Material deformation 3
Tear, rip or hole in device packaging 3
Inadequate user interface 3
Difficult to open or remove packaging material 3
Patient-device incompatibility 3
Material separation 3
Material fragmentation 3
Material disintegration 2
Loss of or failure to bond 2
Melted 2
Product quality issue 2
Device, removal of (non-implant) 2
Material twisted 2
Wrinkled 1
Failure to obtain samples 1
Increased sensitivity 1
Use of Device Issue 1
Device damaged prior to use 1
Device disinfection or sterilization issue 1
Item contaminated during manufacturing or shipping 1
User used incorrect product for intended use 1
Shelf life exceeded 1
Shipping damage or problem 1
Material rigid or stiff 1
Material discolored 1
Disconnection 1
Device expiration issue 1
Material frayed 1
Leak 1
Total Device Problems 342

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 1 0 0 0 1 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Aplicare, Inc. III Apr-08-2010
2 Coloplast Manufacturing US, LLC III Oct-24-2014

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